Lead Mechanical Engineer

vor 1 Monat

Emmendingen, Baden-Württemberg, Deutschland Intuitive Vollzeit

Job Overview

Key Responsibilities:

  • Oversee the mechanical design, implementation, and validation of instruments for the manufacturing, assessment, and calibration of high-quality endoscopic devices.
  • Enhance or automate current machinery as part of ongoing innovations.

Role and Duties:

  • Design and continuously refine production, assessment, and calibration frameworks for endoscopes and their components.
  • Work closely with product and process engineers to understand specifications and create dependable, efficient, and repeatable testing and calibration instruments.
  • Design, specify, prototype, document, source, validate, deploy, and improve devices and their components for production, testing, and calibration. Maintain comprehensive documentation including specifications, validation protocols, assembly instructions, preventive maintenance and calibration (PMC), and manufacturing process instructions (MPIs).
  • Assist in product development (R&D) focusing on Design for Manufacturability and Design for Reliability to ensure standardization of hardware and processes.
  • Adhere to current Quality Management Systems (QMS), Documented Operating Procedures (DOPs), Standard Operating Procedures (SOPs), and safety standards.
  • Contribute to the ongoing enhancement of processes and documentation.
  • As a member of the project team, planning, coordinating, executing, and documenting tests will be integral to your daily responsibilities.
  • Manage the installation, commissioning, ramp-up, and acceptance of machinery and equipment.
  • Possess a passion for advancing traditional mechanics to meet future demands.

Qualifications

Essential Knowledge, Skills, and Experience:

  • Typically requires a minimum of 8 years of relevant professional experience with a Bachelor's degree, or 6 years with a Master's degree; or a doctorate with 3 years of experience; or equivalent professional background.
  • Experience in ISO 9001, or in a medical device manufacturing or other regulated sector.
  • Proficient in 3D CAD (preferably Solid Works) with extensive experience in mechanical systems.
  • Strong expertise in mechanical engineering.
  • Solid understanding in areas such as sampling, prototyping, initial production, component and system evaluation.
  • Ability to coordinate development efforts with external partners and suppliers, ensuring alignment across various departments in interdisciplinary projects.
  • High proficiency in hardware/software specifications and/or systems engineering.
  • Familiarity with Rapid Prototyping (Additive Manufacturing) using the Objet Connex 1 Polyjet process.
  • Strong knowledge in the design and manufacturability of components made from metal and plastic.
  • Extensive experience with agile project management methodologies (Six Sigma, SCRUM Agile, etc.).
  • Good command of MS Office and willingness to learn additional supporting software (Polarion, Agile, etc.).
  • Demonstrated commitment, initiative, strong teamwork abilities, and exceptional problem-solving skills.
  • Fluent in both German and English, with excellent verbal and written communication skills.
  • Willingness to travel occasionally for business purposes.
  • Prepared to work in a controlled environment, including wearing cleanroom attire and adhering to cleanroom protocols.

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